Through synergies with a team of experts (pharmacologists, clinicians and pharmacists) we can support our Clients in the following activities:
– Drafting of European CTD dossiers: Forms I and II (nonclinical and clinical overviews and summaries), assistance in completing Forms 4 and 5
– Drafting of pharmacological reports on environmental impact – Environmental Risk Assessment (ERA)
– Drafting Addendum Clinical Overview (ACO)
– Drafting of scientific articles
– Texts for product presentations, ensuring, if necessary, their publication in trade journals